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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT05373615
Other study ID # HHC-2022-0045
Secondary ID
Status Active, not recruiting
Phase Phase 1
First received
Last updated
Start date July 25, 2022
Est. completion date October 2024

Study information

Verified date February 2024
Source Hartford Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Continuous renal replacement therapies (CRRT) such as continuous venovenous hemofiltration are used to provide renal support for critically ill patients with acute kidney injury (AKI), particularly patients who are hemodynamically unstable. It is well known that critically ill patients may experience alterations in antibiotic pharmacokinetics, and as a result, dosing modifications are generally required. There is a need to understand how CRRT affect the pharmacokinetics and disposition of drugs. This study is designed to assess the pharmacokinetics of the new broad-spectrum antibiotic, Cefiderocol, in critically ill patient receiving CRRT.


Description:

This is a prospective, multi-center, open-label, Phase 1b, pharmacokinetic study of Cefiderocol in 16 critically ill patients receiving CRRT support. Informed consent will be collected from all study participants, legal authorized representative, or their next of kin in order to participate. This is not a treatment study; all participants will receive standard of care antibiotics which may include cefiderocol as necessary to treat any current infection.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 16
Est. completion date October 2024
Est. primary completion date October 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 120 Years
Eligibility Inclusion Criteria: 1. Age 18 years or older; 2. Receiving CRRT including CVVH, CVVHD, and CVVHDF support. Exclusion Criteria: 1. Females who are pregnant or breast-feeding; 2. History of any moderate or severe hypersensitivity or allergic reaction to any ß-lactam antibiotic (a history of mild rash to a cephalosporin followed by uneventful re-exposure is not a contraindication); 3. A hemoglobin less than 8 gm/dl at baseline; 4. Acute liver injury, defined as aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 5 times the upper limit of normal, or AST or ALT > 3 times the upper limit of normal with an associated total bilirubin > 2 times upper limit of normal; 5. Any rapidly-progressing disease or immediately life-threatening illness (defined as imminent death within 48 hours in the opinion of the investigator); 6. Any condition or circumstance that, in the opinion of the investigator, would compromise the safety of the patient or the quality of study data.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Cefiderocol
After receipt of Cefiderocol, blood samples will be collected at various time points to determine the pharmacokinetics of Cefiderocol

Locations

Country Name City State
United States Hartford Hospital Hartford Connecticut

Sponsors (2)

Lead Sponsor Collaborator
Hartford Hospital Shionogi Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Cefiderocol concentration The total and free plasma concentration of cefiderocol over time 8 to 12 hours
Primary Cefiderocol clearance The Clearance in liters/hour of Cefiderocol from the plasma 8 to 12 hours
Primary Cefiderocol maximum concentration The maximum concentration of Cefiderocol from the plasma 8 to 12 hours
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